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BQP Qualification Program Cover Letter BQP Qualification Program Cover Letter Date: March 20, 2020 Subject: DDT QUALIFICATION SUBMISSION DDT Type: Biomarker Qualification ATTN: CDER-Biomarker Qualification Program C/O CDER Document Room: Upon receipt notify: [email protected] Biomarker DDT Tracking Number: (in bold print), if previously assigned Check Submission Type Here P Letter of Intent Qualification Plan Full Qualification Package Update of Above (Check two, this box and one above) Other (please specify): Biomarker Name(s): Individualized Risk Calculator for Psychosis (IRC-P) Context of Use: Describe the intended drug development use for the biomarker named above (1 to 2 sentences, see the graphic below for how to write the context of use.) Prognostic biomarker intended for use in clinical trials. It will be used in conjunction with clinical high- risk for psychosis (CHR-P) or Attenuated Psychosis Syndrome (APS) diagnosis in young people aged 15- 35 years of age, to enrich for individuals most likely to progress to full psychosis and poor long-term functional outcomes. Contact Information: Complete contact information including name(s), affiliation, mailing address, email address, phone and fax numbers. 1. Tyrone Cannon, Principle Investigator, North American Prodrome Longitudinal Study (NAPLS) Research Consortium Clark L. Hull Professor of Psychology and Professor of Psychiatry Yale University P.O. Box 208205, 2 Hillhouse Avenue, New Haven, CT 06520 203-436-1545 [email protected] 2. Linda Brady, Co-chair, Biomarkers Consortium Neuroscience Steering Committee Director, Division of Neuroscience and Basic Behavioral Science (DNBBS) 6001 Executive Boulevard, Room 7204/MSC 9645, Bethesda, MD 20892 BQP Qualification Program Cover Letter (301) 443-3563 [email protected] Purpose Statement: Describe the purpose of the submission in 3-5 sentences. To obtain formal feedback from the FDA regarding an individualized risk calculator for psychosis (IRC- P) as a prognostic biomarker. The IRC-P is proposed for use in future clinical trials and treatment studies to identify a subgroup of individuals meeting criteria for a CHR-P or APS diagnosis, that are most likely to progress to full psychosis and poor long-term functional outcomes (i.e., those most in need of treatment). The replicability of the IRC-P as a prognostic biomarker is being assessed by a multi-consortia international effort called HARMONY (Harmonization of At Risk Multisite Observational Networks for Youth). NAPLS is collaborating with the PRONIA (https://www.pronia.eu) and PSYSCAN (http://psyscan.eu) consortia studies based in Europe that have collected similar information on large cohorts of CHR-P individuals. The purpose of this submission is to solicit feedback from the FDA regarding the viability of the IRC-P as a prognostic biomarker for use in clinical trials, the current plan for conducting confirmatory studies, and next steps for testing the robustness of particular thresholds of predicted risk as cut-points for maximizing sensitivity and specificity of psychosis prediction. In addition, the applicant intends to explore re-analysis of prior clinical trial data on CHR-P samples incorporating individualized predicted risk as a factor in the statistical analysis, to determine whether treatment outcomes are moderated by level of predicted risk. If so, the resulting evidence may help to qualify the IRC-P for an expanded context of use in relation to treatment selection in a stepped care algorithm whereby the particular intervention (e.g., psychological, drug) is targeted/scaled to the individual’s level of predicted risk. Submission Statement: Include a statement in the cover letter that: “The physical media submission is virus free with a description of the software (name, version and company) used to check the files for viruses.” The physical media submission is virus free and has been checked for viruses with ESET Endpoint Antivirus software. Additional Instructions for LOI/QP/FQP1 submissions: For every electronic submission, a comprehensive table of contents should be submitted containing three or four levels of detail, with the appropriate bookmarks to key referenced sections in the document. 1 LOI: Letter of Intent; QP: Qualification Plan; FQP: Full Qualification Plan LOI Outline v2.0, 01/10/2020 Biomarker Qualification Letter of Intent (LOI) Content Elements NOTE TO REQUESTORS: FDA is currently developing its policies for submissions under the 21 Century Cures Act (section 507)1 and expects to issue guidance to aid in the development of submission based on a decade of reviews, input from public meetings, comments to the docket and collaborative public partnerships. In the interim the Agency has assembled this resource to help requestors. Given the changes to the process as defined in section 507, we expect to see further development of this content over time, with more experience and your input. For additional resources on submission content please see prior Biomarker Qualification Program submissions that we have accepted under section 507 HERE. Please also note that certain information contained in submissions will be made publicly available as per section 507, as described in greater detail HERE. Should you have any questions or want to provide feedback on this or other BQP resources, including the content and format of submissions and the transparency provisions under section 507, please contact us at [email protected] COMMENTS: The following information will be made publicly available as per section 507, described in greater detail HERE 1. Section 3011 of the 21st Century Cures Act established section 507 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Table of Contents ADMINISTRATIVE INFORMATION ......................................................................................................................................... 2 DRUG DEVELOPMENT NEED STATEMENT ............................................................................................................................. 3 BIOMARKER INFORMATION AND INTERPRETATION ............................................................................................................. 4 Biomarker measurement ........................................................................................................................................................... 5 CONTEXT OF USE STATEMENT ............................................................................................................................................ 6 ANALYTICAL CONSIDERATIONS ............................................................................................................................................ 7 Biomarker description ................................................................................................................................................................ 7 A standard operating procedure (SOP) for sample collection, storage and test/assay methodology ....................................... 8 Analytical validation plan .......................................................................................................................................................... 8 CLINICAL CONSIDERATIONS ................................................................................................................................................. 9 Clinical Validation ...................................................................................................................................................................... 9 Benefits and Risks of Applying Clinical Decision Tool ................................................................................................................. 9 Describe Knowledge Gaps, Limitations and Assumptions ........................................................................................................ 10 SUPPORTING INFORMATION ............................................................................................................................................. 10 BIOLOGICAL RATIONALE ................................................................................................................................................................. 10 SUMMARY OF EXISTING PRECLINICAL OR CLINICAL DATA ........................................................................................................................ 11 SUMMARY OF ANY PLANNED STUDIES TO SUPPORT THE BIOMARKER AND COU ......................................................................................... 11 ALTERNATIVE/COMPARATOR/CURRENT STANDARD(S) APPROACHES ........................................................................................................ 12 PREVIOUS QUALIFICATION INTERACTIONS AND OTHER APPROVALS (IF APPLICABLE) ....................................................... 12 ATTACHMENTS .................................................................................................................................................................. 13 Publications Relevant to the IRC-P Biomarker Development Proposal .................................................................................... 13 Cannon TD, et al., Am J Psychiatry 2016………………………………………………………………………………………………………………….. 17 Carrion RE, et al. Am J Psychiatry 2016……………………………………………………………………………………………………………………. 26 Zhang T, et al., Am J Psychiatry 2018………………………………………………………………………………………………………………………. 34 Administrative Information 1. Submission Title: Individualized
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